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Swissmedic (Swiss Agency for Therapeutic Products)

publicSwissmedic (Swiss Agency for Therapeutic Products) · Switzerland · Updated Jun 22, 2026

Adoption of ICH E6(R3) Annex 2 for Good Clinical Practice

Urgency: High

MAHs and trial sponsors must align their safety monitoring and data collection workflows with the new GCP principles established in ICH E6(R3) Annex 2.

Inspection ReadinessCAPARegulatory Intelligence Lead
SOP Impact3 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Notice
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Tag: Swissmedic (Swiss Agency for Therapeutic Products) | PV Bulletin